Pugh Jennifer E, Petropoulou Katerina, Vasconcelos Joana C, Anjum Aisha, Thom George, McCombie Louise, Tashkova Martina, Alshehhi Sumayya, Babalis Daphne, Holroyd Leah, Sadiq Barzan A, Prechtl Christina, Preston Tom, Chambers Edward, Lean Mike J, Dhillo Waljit, Prevost A Toby, Morrison Douglas, Frost Gary
Section for Nutrition, Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK.
Nightingale-Saunders Clinical Trials & Epidemiology Unit, King's Clinical Trials Unit, King's College London, London, UK.
EClinicalMedicine. 2024 Sep 25;76:102844. doi: 10.1016/j.eclinm.2024.102844. eCollection 2024 Oct.
Obesity drives metabolic disease development. Preventing weight gain during early adulthood could mitigate later-life chronic disease risk. Increased dietary fibre intake, leading to enhanced colonic microbial fermentation and short-chain fatty acid (SCFA) production, is associated with lower body weight. Despite national food policy recommendations to consume 30 g of dietary fibre daily, only 9% of adults achieve this target. Inulin-propionate ester (IPE) selectively increases the production of the SCFA propionate in the colon. In previous studies, IPE has prevented weight gain in middle-aged adults over 6 months, compared with the inulin control. IPE is a novel food ingredient that can be added to various commonly consumed foods with a potential health benefit. This 12-month study aimed to determine whether using IPE to increase colonic propionate prevents further weight gain in overweight younger adults.
This multi-centre randomised-controlled, double-blind trial was conducted in London and Glasgow, UK. Recruited participants were individuals at risk of weight gain, aged between 20 and 40 years and had an overweight body mass index. Sealed Envelope Software was used to randomise participants to consume 10 g of IPE or inulin (control), once per day for 12 months. The primary outcome was the weight gained from baseline to 12 months, analysed by an 'Intention to Treat' strategy. The safety profile and tolerability of IPE were monitored through adverse events and compliance. This study is registered with the International Standard Randomised Controlled Trials (ISRCT) Database (ISRCT number: 16299902).
Participants (n = 135 per study arm) were recruited from July 2019 to October 2021. At 12 months, there was no significant difference in baseline-adjusted mean weight gain for IPE compared with control (1.02 kg, 95% CI: -0.37 to 2.41; p = 0.15; n = 226). Neither the IPE (+1.22 kg) nor the control arm (+0.07 kg) unadjusted mean gains in body weight reached the expected 2 kg threshold. In the IPE arm, fat-free mass was greater by 1.07 kg (95% CI: 0.21-1.93), and blood glucose elevated by 0.11 mmol/L (95% CI: 0.01-0.21). Compliance, determined by intake of ≥50% sachets, was reached by 63% of IPE participants. There were no unexpected adverse events or safety concerns.
Our study indicates that at 12 months, IPE did not differentially affect weight gain, compared with the inulin control, in adults between 20 and 40 years of age, at risk of obesity.
NIHR EME Programme (15/185/16).
肥胖会促使代谢性疾病的发展。在成年早期预防体重增加可以降低晚年患慢性病的风险。膳食纤维摄入量增加会增强结肠微生物发酵并产生短链脂肪酸（SCFA），这与较低的体重有关。尽管国家食品政策建议每日摄入30克膳食纤维，但只有9%的成年人达到这一目标。菊粉丙酸酯（IPE）可选择性地增加结肠中SCFA丙酸的生成。在之前的研究中，与菊粉对照组相比，IPE在6个月内防止了中年成年人的体重增加。IPE是一种新型食品成分，可以添加到各种常见食物中，具有潜在的健康益处。这项为期12个月的研究旨在确定使用IPE增加结肠丙酸是否能防止超重的年轻成年人进一步体重增加。
这项多中心随机对照双盲试验在英国伦敦和格拉斯哥进行。招募的参与者为有体重增加风险、年龄在20至40岁之间且体重指数超重的个体。使用密封信封软件将参与者随机分为每天食用10克IPE或菊粉（对照组），持续12个月。主要结局是从基线到12个月的体重增加，采用“意向性分析”策略进行分析。通过不良事件和依从性监测IPE的安全性和耐受性。本研究已在国际标准随机对照试验（ISRCT）数据库注册（ISRCT编号：16299902）。
从2019年7月至2021年10月招募了参与者（每个研究组n = 135）。在12个月时，与对照组相比，IPE经基线调整后的平均体重增加无显著差异（1.02千克，95%CI：-0.37至2.41；p = 0.15；n = 226）。IPE组（+1.22千克）和对照组（+0.07千克）未经调整的平均体重增加均未达到预期的2千克阈值。在IPE组中，去脂体重增加了1.07千克（95%CI：从0.21至1.93），血糖升高了0.11毫摩尔/升（95%CI：从0.01至0.21）。通过摄入≥50%的包来确定依从性，63%的IPE参与者达到了这一标准。没有意外的不良事件或安全问题。
我们的研究表明，在12个月时，与菊粉对照组相比，IPE对有肥胖风险的20至40岁成年人的体重增加没有差异影响。
英国国家卫生研究院EME项目（15/185/16）。
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